The FOxTROT Trial
INFORMATION FOR LOCAL PRINCIPAL INVESTIGATORS
For new centres wishing to participate in the FOxTROT Trial
The lead local researcher for a multi-centre study is the local Principal Investigator.
In the FOxTROT trial the role of Local Principal Investigator carries certain responsibilities:
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Day-to-day responsibility for the conduct of the research
Responsible for recruitment into the study at site
For ensuring the Research Governance requirements for the centre and the study are met
To ensure the agreed protocol is followed
Helping care professionals ensure participants receive appropriate care while involved in
the research
The integrity of records and ensuring they are kept confidential
Reporting adverse reactions
All sites require Trust approval from their Local R&D department before the study can
commence at site.
 No patients can be approached for consent to join the trial until this is in place.
 This process is called Site Specific Assessment (SSA). This is gained by the submission of
the Site Specific Information (SSI) Form.
The FOxTROT Trial Office can assist in the approval process if this form is completed and
returned to the FOxTROT study office. The Trial Office will complete the necessary paperwork and
return to the PI for signature and submission. Approval will require liaison between the PI and
the Trust R&D Office to gain approval, but the Trial Office will help as much as possible.
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The local R&D office will assess whether the local PI has the necessary training and
experience to undertake the study.
The local R&D office will require indication of relevant recent research experience.
The local R&D office needs to know who the other investigators are who will have a
significant research role (e.g. clinicians and research nurses).
All investigators should comply with the requirements of the Research Governance
Framework for Health and Social Care. This document can be found on the Department of
Health website: www.dh.gov.uk.
The local R&D office will also wish to be reassured that the PI has time to undertake the
proposed project and fulfil their responsibilities.
The local R&D office will want reassurance that all persons taking consent locally are
appropriately trained for the task, by being aware of the nature of that process and familiar
with “best practice” and that these persons should have sufficient time and expertise to
answer all questions that might be raised by FOxTROT participants.
FOxTROT Site Registration Form
January 2013
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The FOxTROT Trial
Practical Arrangements Form
For all centres wishing to participate in the FOxTROT trial:
Please complete all sections below and return to the FOxTROT Trial Office.
PRINCIPAL INVESTIGATOR
Name:
________________________________________________________
Position:
________________________________________________________
Qualifications: ________________________________________________________
Department:
________________________________________________________
Hospital:
________________________________________________________
Address:
________________________________________________________
________________________________________________________
Telephone:
______________________ Fax:
__________________________
Email:
________________________________________________________
1. Location for research: (To include units/departments for surgery, radiology, pathology,
oncology, location for follow-up.)
Location
Research activity
2. Number of participants expected to be recruited:
a. In the first year?
_____________________
b. For the duration of the study:
_____________________
3. Who will be responsible for obtaining consent at site?
(Anyone taking consent should be GCP trained; a copy of the certificate should be held at site
and will be requested by R&D and the FOxTROT trial office).
NB. Consent for KRAS Screening can be taken by clinicians or research nurses BUT
trial consent can only be taken by clinicians.
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
FOxTROT Site Registration Form
January 2013
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The FOxTROT Trial
4. Is there an independent contact point where potential participants can seek general advice
about participation in research?
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
5. Is there a contact point where potential participants can receive further information about
FOxTROT?
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
6. What local arrangements do you plan to make for participants who do not adequately
understand English?
a. Use PALS interpreter
b. Unlikely to be required
c. Other
7. Name of Clinical Director (or other person responsible for authorisation of research in the
department).
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
8. Is there a clinical trials office or department that BCTU should correspond with to help in the set
up of your site? If so, could you please supply a contact name and contact details?
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
FOxTROT Site Registration Form
January 2013
Page 3 of 5
The FOxTROT Trial
Members of the research team
Additional participating consultant oncologist (other than PI):
Name
________________________________________
Telephone
________________________________________
Fax
________________________________________
E-mail
________________________________________
Approx. how much time will be spent working on the trial? ______________
Participating consultant surgeon:
Name
________________________________________
Telephone
________________________________________
Fax
________________________________________
E-mail
________________________________________
Approx. how much time will be spent working on the trial? ________________
Oncologist – please supply the following pharmacy details (required for the delivery of
panitumumab)
Participating pharmacist:
Name:
________________________________________
Position:
________________________________________
E-mail
________________________________________
Pharmacy Address: ________________________________________
_______________________________________________________
_______________________________________________________
_______________________________________________________
_________________________Post Code ____________________
Participating consultant radiologist:
Name
________________________________________
Telephone
________________________________________
Fax
________________________________________
E-mail
________________________________________
Approx. how much time will be spent working on the trial? ________________
Would you/your Lead Radiologist be able to attend
a Radiology Training Day?
Yes
No
Radiology Training is mandatory – a site must have a FOxTROT trained radiology in order
to open to recruitment.
Participating consultant pathologist :
Name
________________________________________
Telephone
________________________________________
Fax
________________________________________
E-mail
________________________________________
Approx. how much time will be spent working on the trial? ________________
Would you/your Lead Radiologist be able to attend
a Pathology Training Day?
FOxTROT Site Registration Form
Yes
No
January 2013
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The FOxTROT Trial
Participating research nurse:
Name
________________________________________
Telephone
________________________________________
Fax
________________________________________
E-mail
________________________________________
Approx. how much time will be spent working on the trial? _______________
Thank you for the completing the site registration form.
Please return to the FOxTROT Trial Office by post, e-mail or fax:
FOxTROT Trial Office
FREEPOST RRKR-JUZR-HZHG, Birmingham Clinical Trials Unit, School of Cancer
Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT.
FOxTROT-trial@contacts.bham.ac.uk
Trial Coordinator:
Fax: 0121 415 8871
Dr Laura Magill
E-mail: e.l.magill@bham.ac.uk
Please remember to include:
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Signed and dated CVs for all lead researchers
GCP certificates when available
Laboratory accreditation certificates and normal lab reference ranges (required for
supply of panitumumab)
Local Trust headed paper (electronic version)
FOxTROT Site Registration Form
January 2013
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